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NDC 58411-0124-30 SHISEIDO UV PROTECTIVE COMPACT (REFILL) 888; 600; 1416 mg/12g; mg/12g; mg/12g Details

SHISEIDO UV PROTECTIVE COMPACT (REFILL) 888; 600; 1416 mg/12g; mg/12g; mg/12g

SHISEIDO UV PROTECTIVE COMPACT (REFILL) is a TOPICAL POWDER in the HUMAN OTC DRUG category. It is labeled and distributed by SHISEIDO AMERICAS CORPORATION. The primary component is OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE.

Product Information

NDC	58411-0124
Product ID	58411-124_7cf0df6c-a1ae-a663-e053-2a91aa0ac50f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	SHISEIDO UV PROTECTIVE COMPACT (REFILL)
Proprietary Name Suffix	LIGHT OCHRE
Non-Proprietary Name	OCTINOXATE, OCTOCRYLENE, and TITANIUM DIOXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER
Route	TOPICAL
Active Ingredient Strength	888; 600; 1416
Active Ingredient Units	mg/12g; mg/12g; mg/12g
Substance Name	OCTINOXATE; OCTOCRYLENE; TITANIUM DIOXIDE
Labeler Name	SHISEIDO AMERICAS CORPORATION
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 58411-0124-30 (58411012430)

Pricing Information	N/A
NDC Package Code	58411-124-30
Billing NDC	58411012430
Package	1 TRAY in 1 CARTON (58411-124-30) / 12 g in 1 TRAY
Marketing Start Date	2014-02-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL c05cef12-a6a7-4682-9357-6d77f4ca3267 Details

SPL UNCLASSIFIED SECTION

Drug Facts

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS:	Purpose
OCTINOXATE 7.4%	Sunscreen
OCTOCRYLENE 5.0%	Sunscreen
TITANIUM DIOXIDE 11.8%	Sunscreen

Uses

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

apply liberally 15 minutes before sun exposure
use a water resistant sunscreen if swimming or sweating
reapply at least every 2 hours
Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. – 2 p.m.
- wear long-sleeve shirts, pants, hats, and sunglasses
children under 6 months: Ask a doctor

Inactive Ingredients

SYNTHETIC FLUORPHLOGOPITE,DIMETHICONE,SILICA,NYLON-12,VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER,PETROLATUM,METHICONE,TRIETHYLHEXANOIN,PEG/PPG-14/7 DIMETHYL ETHER,TOCOPHERYL ACETATE,SAXIFRAGA SARMENTOSA EXTRACT,SODIUM HYALURONATE,SOPHORA ANGUSTIFOLIA ROOT EXTRACT,SORBITAN SESQUIISOSTEARATE,HYDROGEN DIMETHICONE,ALUMINUM HYDROXIDE,WATER,POLYSILICONE-2,ALCOHOL,SODIUM MAGNESIUM SILICATE,HYDRATED SILICA,TRIETHOXYCAPRYLYLSILANE,ALUMINUM DISTEARATE,BUTYLENE GLYCOL,GLYCERIN,TOCOPHEROL,BHT,DISTEARYLDIMONIUM CHLORIDE,SYZYGIUM JAMBOS LEAF EXTRACT,TIN OXIDE,CHLORPHENESIN,FRAGRANCE,MICA,TITANIUM DIOXIDE,IRON OXIDES,ZINC OXIDE,

Other information

protect this product in this container from excessive heat and direct sun.

Questions or comments?

Call toll free 1-800-906-7503

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Fair Ivory

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Fair Ivory

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Beige

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Light Beige

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Ivory

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Light Ivory

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Ochre

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Light Ochre

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Beige

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Medium Beige

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Ivory

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Medium Ivory

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Ochre

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Medium Ochre

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Dark Beige

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Dark Beige

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Dark Ivory

SHI SEIDO

Anti-Aging Foundation

UV Protective

Compact Foundation

(Refill)

BROAD SPECTRUM

SPF 36

SUNSCREEN

12g NET WT. .42 OZ.

Principal Display Panel - 12 g Tray Carton - Dark Ivory

INGREDIENTS AND APPEARANCE

SHISEIDO UV PROTECTIVE COMPACT (REFILL) FAIR IVORY

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-121
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-121-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT BEIGE

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-122
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-122-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT IVORY

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-123
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-123-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE COMPACT (REFILL) LIGHT OCHRE

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-124
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-124-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM BEIGE

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-125
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-125-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM IVORY

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-126
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-126-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE COMPACT (REFILL) MEDIUM OCHRE

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-127
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-127-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK BEIGE

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-128
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-128-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

SHISEIDO UV PROTECTIVE COMPACT (REFILL) DARK IVORY

octinoxate, octocrylene, and titanium dioxide powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:58411-129
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	888 mg in 12 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	600 mg in 12 g
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	1416 mg in 12 g

Ingredient Name	Strength
Inactive Ingredients
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
NYLON-12 (UNII: 446U8J075B)
PETROLATUM (UNII: 4T6H12BN9U)
METHICONE (20 CST) (UNII: 6777U11MKT)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
SAXIFRAGA STOLONIFERA LEAF (UNII: O3TMV4903H)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
SOPHORA FLAVESCENS ROOT (UNII: IYR6K8KQ5K)
ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
ALUMINUM DISTEARATE (UNII: 7P1HP1B9UI)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
SYZYGIUM JAMBOS LEAF (UNII: 407Z4W5LFF)
STANNIC OXIDE (UNII: KM7N50LOS6)
CHLORPHENESIN (UNII: I670DAL4SZ)
MICA (UNII: V8A1AW0880)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
ZINC OXIDE (UNII: SOI2LOH54Z)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:58411-129-30	1 in 1 CARTON	02/01/2014
1		12 g in 1 TRAY; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	02/01/2014

Labeler - SHISEIDO AMERICAS CORPORATION (193691821)

Name	Address	ID/FEI	Business Operations
Establishment
SHISEIDO AMERICA INC.		782677132	manufacture(58411-121, 58411-122, 58411-123, 58411-124, 58411-125, 58411-126, 58411-127, 58411-128, 58411-129) , analysis(58411-121, 58411-122, 58411-123, 58411-124, 58411-125, 58411-126, 58411-127, 58411-128, 58411-129)

Revised: 12/2018

Document Id: 7cf0df6c-a1ae-a663-e053-2a91aa0ac50f

Set id: c05cef12-a6a7-4682-9357-6d77f4ca3267

Version: 2

Effective Time: 20181213

Search by Drug Name or NDC

NDC 58411-0124-30 SHISEIDO UV PROTECTIVE COMPACT (REFILL) 888; 600; 1416 mg/12g; mg/12g; mg/12g Details

SHISEIDO UV PROTECTIVE COMPACT (REFILL) 888; 600; 1416 mg/12g; mg/12g; mg/12g

Product Information

Package

Package Images

NDC 58411-0124-30 (58411012430)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL c05cef12-a6a7-4682-9357-6d77f4ca3267 Details

SPL UNCLASSIFIED SECTION

SPL UNCLASSIFIED SECTION

Uses

Warnings

Directions

Inactive Ingredients

Other information

Questions or comments?

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Fair Ivory

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Beige

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Ivory

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Light Ochre

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Beige

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Ivory

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Medium Ochre

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Dark Beige

PRINCIPAL DISPLAY PANEL - 12 g Tray Carton - Dark Ivory

INGREDIENTS AND APPEARANCE

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